76-13-B2

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Drugs and the FDA

Transcript A bill to curb some of the bureaucratic fumbling in the federal drug administration defeated in the 94th Congress has another chance in the 95th. I'll be right back. Congressman Steve Symms of Idaho has 87 co-sponsors of the House of Representatives on a bill quote "to expand the medical freedom of choice of consumers by amending the federal Food Drug and Cosmetic Act to provide that drugs will be regulated under that act solely to assure their safety." unquote. Now, how many of us thought that safety was the only concern of the Federal Drug Administration the FDA. We have so many laws and we add so many more each year it's understandable if we fail to note or to remember that in 1962 the Federal Drug Act was amended to say that drugs and medicine should not only be safe, they must also be effective. The late senator Estes Kefauver chaired the antitrust and monopoly subcommittee, which was investigating prices of new drugs. About that time the tragic thalidomide disaster hit West Germany. It had not been licensed in America. It could not have been licensed under our laws as they were then, but tragedy was used to push through, in emergency fashion, a bill granting additional power to the FDA. The result of that hasty panic inspired amendment has hardly benefited the American people. In the first place, deciding a medicine is safe to take is one thing, but trying to establish its effectiveness is something else again. Doctors over the years have displayed a great ability to sort out medicines which aren't very effective. If aspirin hadn't been approved prior to the 1962 amendment, it might not be on the market today. Prior to the amendment, United States drug companies added an average of 43 new medicines each year. Now we're down to 13. It used to take one or two years to get a medicine licensed and at a cost of about 1 million dollars. Now it takes 8 to 10 years, at a cost sometimes as high as 20 million dollars. The average is about 12 million. With all of government's concern about eliminating monopoly, the 1962 amendment encouraged monopoly. Only the very biggest drug firms can afford to develop new medicines now. Our government almost automatically accepts foreign studies showing that a drug is not good. It does not, however, accept such studies if they find the drug is good. Many American discoveries are denied to the American people but are licensed and used effectively in the rest of the world. 3/4 of new drugs developed in the United States are barred to us but sold overseas. Take the case of an American arthritis discovery. It's been given extensive tests in 15 countries, is sold in more than 40, and there have been about a hundred and twenty million patient hours of use. It is not available in the United States. What price have we paid in suffering and death because of the arrogance of officialdom. One FDA official boasted that he had held up for 9 and 1/2 years any drug for angina pectoris and hypertension because in his opinion these are symptoms and not diseases. The doctor who prescribes the medication is best able to judge his effectiveness. Congressman Steve Symms says quote "The health of Americans should never be subjected to the whims of Congress. The only long-term solution is to take away from FDA, the power to make the terribly subjective determinations about drug effectiveness" unquote. Steve Symms has offered a pro-consumer, anti-monopoly bill. It is known as House Resolution 54. He could use our help. This is Ronald Reagan. Thanks for listening.		Details Batch Number 76-13-B2 Production Date 05/04/1977 Book/Page RihoH-297 Audio Yes Youtube? No
		Added Notes Thalidomide (Wikipedia)